Understanding the Scope and Claims of United States Patent 5,575,987
Introduction
United States Patent 5,575,987, hereafter referred to as the '987 patent, is a critical intellectual property asset that has been involved in significant legal and commercial activities. This patent, owned by Takeda, is associated with the drug Leuprolide Acetate for Depot Injection, a medication used for various medical conditions, including prostate cancer and endometriosis.
Patent Overview
The '987 patent was issued to protect specific methods and compositions related to Leuprolide Acetate, a synthetic nonapeptide analog of the naturally occurring gonadotropin-releasing hormone (GnRH)[2].
Claims Analysis
Key Claims
The '987 patent includes several key claims that define the scope of the invention. These claims typically cover:
- Composition Claims: These pertain to the specific formulation of Leuprolide Acetate, including the sustained-release composition and the method of producing it.
- Method Claims: These cover the processes involved in manufacturing the sustained-release microcapsules and the method of administering the drug.
- Use Claims: These claims specify the medical conditions for which the drug is intended, such as prostate cancer, endometriosis, and precocious puberty.
Claim Scope and Concepts
To understand the full scope of the '987 patent, it is essential to analyze the claims in the context of the broader patent landscape. This involves categorizing the claims by their scope concepts, which can help in identifying gaps or opportunities in the patent coverage. For instance, using a Claim Coverage Matrix, as described in patent analytics, can show which patents and claims are actively protecting the intellectual property and where there might be gaps or future design opportunities[3].
Patent Landscape
Related Patents
The '987 patent is part of a larger family of patents related to Leuprolide Acetate. Other patents in this family include:
- US 4,652,441
- US 4,677,191
- US 4,728,721
- US 4,849,228
- US 4,917,893
- US 5,476,663
- US 5,631,020
- US 5,631,021
- US 5,716,640
These patents collectively protect various aspects of the drug, including different formulations, manufacturing processes, and methods of administration[2].
Global Patent Protection
While the '987 patent provides exclusivity within the United States, it is crucial to understand the global patent landscape for Leuprolide Acetate. The drug is protected by patents in multiple countries, and analyzing these family patents can help identify markets with weaker patent protection, which could be ideal for generic entry points[4].
Legal and Commercial Implications
Patent Infringement
The '987 patent has been involved in significant litigation. For example, Takeda has sued companies like OWL Pharmaceuticals and Oakwood Laboratories for patent infringement related to their Abbreviated New Drug Application (ANDA) for Leuprolide Acetate for Depot Injection. The lawsuit sought to prevent the commercial manufacture, use, and sale of the drug before the expiration of Takeda's patents[2].
Patent Expiry and Generic Launch
The expiry dates of patents like the '987 patent are critical for determining when generic versions of the drug can be launched. However, these dates can be affected by various legal activities such as patent term extensions, amendments to claims, or the abandonment of patents. Tracking these activities is essential for understanding the latest developments in the patent process and predicting the generic launch date[4].
Tools and Resources for Analysis
Patent Public Search
The USPTO's Patent Public Search tool is a powerful resource for analyzing patents like the '987 patent. This tool provides enhanced access to prior art and allows users to search and analyze large volumes of patent data efficiently[1].
Global Dossier
The Global Dossier service offers access to the file histories of related applications from participating IP Offices, including the IP5 Offices. This service can help users identify the patent family for a specific application and access dossier, classification, and citation data[1].
Patent Analytics
Patent analytics tools, such as those provided by Schwegman, can help in categorizing patents by claims and scope concepts. These tools generate interactive claim charts that can be reviewed by technical experts to determine the applicability of specific scope concepts to target products or methods[3].
Key Takeaways
- Patent Claims: The '987 patent includes composition, method, and use claims that define the scope of the invention.
- Patent Landscape: The patent is part of a larger family of patents related to Leuprolide Acetate, with global protection in multiple countries.
- Legal Implications: The patent has been involved in significant litigation related to patent infringement.
- Commercial Impact: The expiry dates of the patent and related legal activities are crucial for determining generic launch dates.
- Analysis Tools: Resources like the USPTO's Patent Public Search, Global Dossier, and patent analytics tools are essential for a comprehensive analysis.
FAQs
Q: What is the main subject of United States Patent 5,575,987?
A: The main subject of the '987 patent is the sustained-release composition and method of producing Leuprolide Acetate for Depot Injection.
Q: Which company owns the '987 patent?
A: The '987 patent is owned by Takeda.
Q: What legal actions have been taken related to the '987 patent?
A: Takeda has sued companies for patent infringement related to their ANDA for Leuprolide Acetate for Depot Injection.
Q: How can the expiry date of the '987 patent be affected?
A: The expiry date can be affected by legal activities such as patent term extensions, amendments to claims, or the abandonment of patents.
Q: What tools are available for analyzing the '987 patent and its landscape?
A: Tools include the USPTO's Patent Public Search, Global Dossier, and patent analytics software like ClaimScape®.
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN: https://insight.rpxcorp.com/litigation_documents/15503683
- Patent Analytics | Intellectual Property Law: https://www.slwip.com/services/patent-analytics/
- Lupron Depot-ped Kit patent expiration: https://pharsight.greyb.com/drug/lupron-depot--ped-kit-patent-expiration
